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Johns Hopkins University Ordered to Halt Human Research

The federal Office of Human Research Protections yesterday ordered Johns Hopkins University to halt all federally funded human medical experiments after concluding that "widespread lapses in safety procedures" contributed to the June death of a 24-year-old woman who participated in an asthma study, the Baltimore Sun reports. The university -- whose hospital was just days ago named the nation's top medical center for the 11th straight year by U.S. News and World Report -- was the largest beneficiary of NIH funding of any medical school last year at $419 million, of which $277 million was designated for human research. The "stunning blow" from the OHRP will affect 2,400 current studies that involve at least 15,000 patients and volunteers. In a letter to Hopkins filled with what the Sun calls "sweeping and often stinging criticism," the OHRP cited multiple safety failures by the lead researcher, Dr. Alkis Togias, in the asthma study that resulted in Ellen Roche's death and by the university's institutional review board responsible for approving the study (Bor/Pelton, Baltimore Sun, 7/20). The letter, which came three days after Hopkins officials also "blamed" Togias and the review board for safety lapses after conducting an internal investigation, said that Togias failed to provide to the board "critical information" about the experimental substance, hexamethonium, that was being tested on the study participants in inhaled form, including its risks. In addition, the report found that despite conducting a literature review, Togias failed to find "readily available" information about the link between hexamethonium and lung toxicity; the drug, which has never been approved by the FDA in inhaled form, eventually "triggered acute respiratory distress" in Roche, leading to her death (Levine/Weiss, Washington Post, 7/20).

'Serious' Problems

The OHRP also faulted Hopkin's institutional review boards for both their approval of the asthma study and for an overall failure to "adequately supervise human experiments throughout the institution," despite being warned about problems last October. The OHRP said yesterday that they had uncovered "multiple instances" in which the "risks outlined in applications for IRB approval were different from those in the consent forms shown to volunteers" and where the language in consent forms was "complex" and difficult for participants to understand, the Sun reports. Bill Hall, an OHRP spokesperson, said, "The bottom line is we found serious problems with their procedures to protect human lives during trials. This is not a paper-pushing procedure. This is about protecting people's lives." The federal order, however, does allow Hopkins studies involving patients with life-threatening illnesses to continue (Baltimore Sun, 7/20). To have the temporary ban lifted, "the university will have to address the concerns raised in the letter restructure its system for protecting human subjects and develop a plan to make sure its ethics committee and researchers are educated in the regulatory requirements for protecting human research subjects," the New York Times reports (Kolata, New York Times, 7/20).

A 'Draconian' Response

In a statement, Johns Hopkins called the OHRP order "unwarranted, unnecessary, paralyzing and precipitous," saying that it could threaten the lives of patients currently enrolled in clinical trials (Zitner, Los Angeles Times, 7/20). Dr. Edward Miller, Hopkins' School of Medicine CEO and medical dean, said, "We are outraged by the actions of the OHRP." Referring to the agency's creation last year, he added, "We find it hard to understand how a new agency would take a draconian measure against an institution that has been conducting trials for thousands of patients over many years ... and providing medical care for more than a century." Responding directly to the criticisms outlined in the OHRP letter, Miller said that the university responded to the agency after receiving its October letter, and said that the OHRP "never responded nor [gave] Hopkins an opportunity to address any remaining concerns," the Sun reports. Miller also characterized many of the OHRP complaints as "bureaucratic," citing criticism about the "length of time it took Hopkins review board to type the minutes of their meetings." Miller said he "expected" that the university would be able to "address" the OHRP criticisms and "persuade" the OHRP to lift the ban "within three or four days -- a timeline an agency official said was possible," the Sun reports (Baltimore Sun, 7/20). The university has already met one of the OHRP's suggestion by creating a third institutional review board to cope with the increasing volume of human research (Washington Post, 7/20). And Maryland Sens. Paul Sarbanes (D) and Barbara Milkulski (D) sent letters to HHS Secretary Tommy Thompson asking him not to implement any suspension until Hopkins officials "could explain themselves" (Baltimore Sun, 7/20). The full Hopkins statement is available at http://www.baltimoresun.com/news/health/bal-hopkinsreacts.story?coll=bal%2Dhome%2Dheadlines.

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